APL IGA ELISA KIT


Device Classification Name

system, test, anticardiolipin immunological

510(k) Number K021398
Device Name APL IGA ELISA KIT
Original Applicant
LOUISVILLE APL DIAGNOSTICS, INC.
3988 flowers rd., suite 620
doraville, 
GA 
30360

Original Contact silvia s pierangeli
Regulation Number 866.5660
Classification Product Code
MID  
Date Received 05/02/2002
Decision Date 08/27/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Immunology

510k Review Panel

Immunology

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No